Drug Facts

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only.

When using this product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

condition worsens or does not improve after regular use of this product as directed.

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

for best results use at least twice a week or as directed by a doctor.
for maximum dandruff control, use every time you shampoo.
shake before use.
wet hair, massage onto scalp, rinse, repeat if desired.

Inactive ingredients

Water, sodium lauryl sulfate, glycol distearate, zinc carbonate, sodium chloride, cocamidopropyl betaine, fragrance, sodium xylenesulfonate, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride,magnesium carbonate hydroxide, sodium laureth sulfate,methylchloroisothiazolinone, methylisothiazolinone

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 380 mL Bottle Label

head &
shoulders ®

pyrithione zinc dandruff

shampoo + conditioner

SMOOTH & SILKY

2in1

24 hour frizz control from root to tip

FLAKE FREE.*

UP TO 100%

GUARANTEED^

12.5 FL OZ (370 mL)

HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37000-095
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC CARBONATE (UNII: EQR32Y7H0M)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37000-095-20	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013	01/02/2017
2	NDC:37000-095-70	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013	11/10/2019
3	NDC:37000-095-40	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/14/2014	11/10/2019
4	NDC:37000-095-25	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/14/2014	03/01/2021
5	NDC:37000-095-95	950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/01/2016	11/10/2019
6	NDC:37000-095-38	380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2017	01/15/2025
7	NDC:37000-095-65	650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2017	01/15/2025
8	NDC:37000-095-93	930 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/11/2017	01/15/2025
9	NDC:37000-095-12	1280 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/29/2020	01/15/2025
10	NDC:37000-095-37	370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/15/2023
11	NDC:37000-095-61	613 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/15/2023
12	NDC:37000-095-83	835 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/15/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M032	09/01/2013

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Head and Shoulders ® Smooth and Silky 2in1